Transforming Clinical Trials in Cardiovascular Disease Mission Critical for Health and Economic Well-being

摘要

Quality of RCTs. In addition to design issues, the quality of RCTs must be addressed. Inadequate attention to the conduct of an RCT can jeopardize the ability to interpret it, as well as its suitability for informing clinical practice. A hallmark of most interventions in CVD is that the treatment effect in both absolute and relative terms is typically modest and incremental beyond comparator therapies. Coupled with a declining rate of CVD events,1 trials designed to establish therapeutic efficacy in CVD require large sample sizes, threatening the collective ability to conduct the RCTs to establish the value of new therapeutic interventions.